Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175680
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.


Condition or disease Intervention/treatment Phase
HIV Human Immunodeficiency Virus Drug: PRO 140 350mg weekly SQ injection. Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
 Drug: PRO 140 350mg weekly SQ injection.
CCR5 Antagonist


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :
  1. Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ]
  2. Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  3. Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  4. Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
  5. Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 Weeks ]

Other Outcome Measures:
  1. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: 14 Weeks ]
  2. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ]
  3. Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
  3. On stable antiretroviral therapy for last 12 months
  4. Subject has two or more potential alternative antiretroviral regimen options to consider.
  5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit
  6. Nadir CD4 cell count of >200 cells/mm3

Exclusion Criteria:

  1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
  3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
  4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
  5. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175680


Locations
Layout table for location information
United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
Sponsors and Collaborators
CytoDyn, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jacob Lalezari, MD
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT02175680    
Other Study ID Numbers: PRO 140_CD 01
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Keywords provided by CytoDyn, Inc.:
HIV-1
HIV
Treatment Substitution
PRO 140
 PRO140
CytoDyn
Amarex
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Leronlimab
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents